The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

NCT ID: NCT01133431

Last Updated: 2010-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-08-31

Brief Summary

To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.

Conditions

Healthy Male Volunteer

Keywords

CKD-501; Glimepiride; Placebo; Healthy male volunteer; Pharmacokinetic; Metabolite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Group Type: EXPERIMENTAL

CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

Intervention Type: DRUG

From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.

CKD-501 placebo tablet, Glimepiride 4 mg tablet

Intervention Type: DRUG

From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.

CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Group Type: EXPERIMENTAL

CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

Intervention Type: DRUG

From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.

CKD-501 placebo tablet, Glimepiride 4 mg tablet

Intervention Type: DRUG

From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.

Interventions

CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.

Intervention Type: DRUG

CKD-501 placebo tablet, Glimepiride 4 mg tablet

From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.

Intervention Type: DRUG

Other Intervention Names

CKD-501 : Lobeglitazone; CKD-501 : Lobeglitazone

Eligibility Criteria

Inclusion Criteria

• Healthy male adults aged between 20 and 45 during screening period
• Weight more than 45kg and within ±20% range of Ideal Boby Weight
• Agreement with written informed consent

Exclusion Criteria

• Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
• Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
• Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
• Inadequate laboratory test result

• AST(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
• Total bilirubin > 1.5 x upper limit of normal range
• Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
• Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
• Previously participated in other trial within 60 days
• Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
• Subject has taken abnormal meals which affects the ADME of drug
• Impossible to taking the institutional standard meal
• Previously donate whole blood within 60 days or component blood within 20 days
• Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
• An impossible one who participates in clinical trial by investigator's decision including laboratory test result

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chong Kun Dang Pharmaceutical

Principal Investigators

Ji Young Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

The Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CKD-19HPS10A

Identifier Type: -

Identifier Source: org_study_id